DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2003

Draft guidances published in the Federal Register in: Current Year | 2005 | 2004| 2003| 2002| 2001| 2000| 1999

Final guidance published in the Federal Register in: Current Year | 2005| 2004| 2003| 2002| 2001} 2000| 1999

Draft Guidances

December

Vol. 68 (December 30, 2003): Docket No. 2003D-0549.  Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision; Availability.  Pages  75262-75263 [FR Doc. 03-31917]  [ TXT ] [ PDF ] Electronic comments by March 1, 2004

The Draft Guidance (PDF)
The Draft Guidance Word)

Vol. 68 (December 2, 2003): Docket No. 2003D-0522.  Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability.  Pages  67460-67461 [FR Doc. 03-29855]  [ TXT ] [ PDF ] Comments due March 1, 2004

The Draft Guidance

Vol. 68 (December 1, 2003): Docket No. 2003D-0391.  Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys; Availability.  Pages  67196-67197 [FR Doc. 03-29740]  [ TXT ] [ PDF ] Comments Due March 4, 2004

The Draft Guidance Precious Metal Alloy Guidance
The Draft Guidance Base Metal Alloy Guidance

November

Vol. 68 (November 13, 2003): Docket No. 2003D-0474.  International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake;" Availability.  Pages  64354-64356 [FR Doc. 03-28373]  [ TXT ] [ PDF ] Comments due December 15, 2003

The Draft Guidance

Vol. 68 (November 7, 2003): Docket No. 2003D-0493.  Draft Guidance for Industry on Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment; Availability (Notice).  Pages  63109-63110 [FR Doc. 03-28045]  [ TXT ] [ PDF ] Comments by March 8, 2004

The Draft Guidance (Word)
The Draft Guidance (pdf)

Vol. 68 (November 4, 2003): Docket No. 2003D-0497.  Draft Guidance for Industry on Pharmacogenomic Data Submissions; Availability.  Pages  62461-62463 [FR Doc. 03-27646]  [ TXT ] [ PDF ] Comments on guidance January 5, 2004

The Draft Guidance (Word)
The Draft Guidance (PDF)

October

Vol. 68 (October 28, 2003): Docket No. 2003D-0383.  Draft Guidance for Industry and FDA Staff; Use of Symbols on labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability.  Pages  61449-61451 [FR Doc. 03-27117]  [ TXT ] [ PDF ] Comments on Information Collection December 29, 2003 Comments by November 28, 2003

The Draft Guidance

Vol. 68 (October 23, 2003): Docket No. 2003D-0478.  Draft Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability.  Pages  60702-60703 [FR Doc. 03-26753 ]  [ TXT ] [ PDF ] Comments due December 22, 2003

The Draft Guidance (PDF)
The Draft Guidance (Word)

Vol. 68 (October 22, 2003): Docket No. 2003D-0465.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--General Considerations; Availability.  Page  60395 [FR Doc. 03-26571]  [ TXT ] [ PDF ] Comments December 22, 2003

The Draft Guidance (PDF)
The Draft Guidance (Word)

September

Vol. 68 (September 17, 2003): Docket No. 03D-0379  Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability.  Pages  54462-54464 [FR Doc. 03-23623 ]  [ TXT ] [ PDF ] Comments November 17, 2003

The Draft Guidance

Vol. 68 (September 15, 2003): Docket No. 03D-0412.  International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting; Availability.  Pages  53983-53984 [FR Doc. 03-23508]  [ TXT ] [ PDF ] Comments October 20, 2003

The Draft Guidance

Vol. 68 (September 5, 2003): Docket No. 03D-0382.  Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing.  Pages  52782-52783 [FR Doc. 03-22576]  [ TXT ] [ PDF ] Comments November 4, 2003

The Draft Guidance

Vol. 68 (September 5, 2003): Docket No. 03D-0380.  Draft Guidance for Industry: Process Analytical Technology--A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability.  Pages  52781-52782 [FR Doc. 03-22578]  [ TXT ] [ PDF ] Comments November 5, 2003

The Draft Guidance

Vol. 68 (September 5, 2003): Docket No. 03D-0386.  Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Availability.  Pages  52777-52779 [FR Doc. 03-22575]  [ TXT ] [ PDF ] Comments on draft guidance March 5, 2004 Comments on Collection of Information November 4, 2003

The Draft Guidance

Vol. 68 (September 5, 2003): Docket No. 03D-0385.  Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information; Availability.  Pages  52776-52777 [FR Doc. 03-22577]  [ TXT ] [ PDF ] Comments December 4, 2003

The Draft Guidance

August

Vol. 68 (August 29, 2003): Docket No. 03D-0367.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions; Availability.  Pages  52044--52045 [FR Doc. 03-22183 ]  [ TXT ] [ PDF ] Comments October 28, 2003

The Draft Guidance

Vol. 68 (August 28, 2003): Docket No. 03D-0364.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug Applications and Abbreviated New Drug Applications; Availability.  Pages  51788--51790 [FR Doc. 03-21985 ]  [ TXT ] [ PDF ] Comments October 27, 2003

The Draft Guidance

Vol. 68 (August 28, 2003): Docket No. 03D-0165  Draft Guidance for Industry on the Current Good Manufacturing Practices for Medical Gases; Availability; Extension of Comment Period.  Page  51790 [FR Doc. 03-21984 ]  [ TXT ] [ PDF ] Comments November 3, 2003

Vol. 68 (August 22, 2003): Docket No. 99D-4577.  Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma; Withdrawal of Draft Guidance.  Page  50804 [FR Doc. 03-21477 ]  [ TXT ] [ PDF ] Effective September 22, 2003

Vol. 68 (August 18, 2003): Docket No. 03D-0349.  Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs).  Pages  49488--49489 [FR Doc. 03-20950 ]  [ TXT ] [ PDF ] Comments November 17, 2003

The Guidance

July

Vol. 68 (July 28, 2003): Docket No. 03D-0317.  Draft Guidance for Reviewers and Industry on Good Review Management Principles for Prescription Drug User Fee Act Products; Availability.  Pages  44345--44346 [FR Doc. 03-19026]  [ TXT ] [ PDF ] Comments September 11, 2003

The Draft Guidance

Vol. 68 (July 24, 2003): Docket No. 03D-0319.  Draft Guidance for Industry and FDA Staff; Premarket Assessment of Pediatric Medical Devices; Availability.  Pages  43729--43730 [FR Doc. 03-18909]  [ TXT ] [ PDF ] Comments October 22, 2003

The Draft Guidance

Vol. 68 (July 23, 2003): Docket No. 03D-0263.  Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency; Availability.  Pages  43535-43538 [FR Doc. 03-18634]  [ TXT ] [ PDF ] Comments September 22, 2003

The Draft Guidance

Vol. 68 (July 11, 2003): Docket No. 03N-0069.  Release of Task Force Report; Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data;Interim Procedures for Health Claims on the Labeling of Conventional Human Food and Human Dietary Supplements; Availability.  Pages  41387--41390 [FR Doc. 03-17702]  [ TXT ] [ PDF ]

The Guidance Interim Evidence-based Ranking System for Scientific Data. Word
The Guidance Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements Word
The Guidance Interim Evidence-based Ranking System for Scientific Data. pdf version
The Guidance Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements pdf version

June

Vol. 68 (June 26, 2003): Docket No. 03D-0236.  Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis Availability.  Pages  38083--38084 [FR Doc. 03-16241 ]  [ TXT ] [ PDF ] Comments September 24, 2003

The Draft Guidance

Vol. 68 (June 24, 2003): Docket No. 03D-0231.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports; Availability.  Pages  37504--37505 [FR Doc. 03-15889 ]  [ TXT ] [ PDF ] Comments August 25, 2003

The Draft Guidance pdf version
The Draft Guidance Word version

Vol. 68 (June 23, 2003): Docket No. 03D-0226.  Draft Guidance for Industry and FDA Staff; Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002--Identification of Manufacturer of Medical Devices; Availability.  Pages  37161--37162 [FR Doc. 03-15731]  [ TXT ] [ PDF ] Comments September 22, 2003

The Draft Guidance

Vol. 68 (June 17, 2003): Docket No. 03D-0229.  Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act.  Page  35903 [FR Doc. 03-15167]  [ TXT ] [ PDF ] Comments August 1, 2003

The Draft Guidance

Vol. 68 (June 17, 2003): Docket No. 03D-0228.  Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Act.  Pages  35901-35903 [FR Doc. 03-15168]  [ TXT ] [ PDF ] Comments August 1, 2003

The Draft Guidance

Vol. 68 (June 12, 2003): Docket No. 03D-0051.  International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on "Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals With Respect to Antimicrobial Resistance" (VICH GL27); Request for Comments; Availability.  Pages  35234--35235 [FR Doc. 03-14822]  [ TXT ] [ PDF ] Comments July 14, 2003

The Draft Guidance

Vol. 68 (June 12, 2003): Docket No. 98D-0727.  Interpretation of On-Farm Feed Manufacturing and Mixing Operations; Withdrawal of Draft Guidance.  Pages  35233--35234 [FR Doc. 03-14820]  [ TXT ] [ PDF ]

May

Vol. 68 (May 19, 2003): Docket No. 03D-0167.  Draft guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability.  Pages  27094-27096 [FR Doc. 03-12369]  [ TXT ] [ PDF ] Comments on Guidance August 4, 2003 Comments on Information Collection July 18, 2003

The Draft Guidance

Vol. 68 (May 19, 2003): Docket No. 98D-0785.  Draft Guidances for Industry on Medical Imaging Drug and Biological Products; Availability.  Pages  27008-27009 [FR Doc. 03-12370]  [ TXT ] [ PDF ] Comments June 18, 2003

The Draft Guidance Part I (Word)
The Draft Guidance Part I (PDF)
The Draft Guidance Part II (PDF)
The Draft Guidance Part II (Word)
The Draft Guidance Part III (PDF)
The Draft Guidance Part III (Word)

Vol. 68 (May 16, 2003): Docket No. 03D-0186.  Draft Guidance for Industry: Use of Material From Deer and Elk in Animal Feed; Availability.  Pages  26628 -26629 [FR Doc. 03-12363 ]  [ TXT ] [ PDF ] Comments June 16, 2003

The Draft Guidance

Vol. 68 (May 15, 2003): Docket No. 03D-0137.  Medical Devices: Draft Guidance for Industry and FDA; Surgical Masks--Premarket Notification Submissions; Availability.  Pages  26308-26309 [FR Doc. 03-12193]  [ TXT ] [ PDF ] Comments June 16, 2003

The Draft Guidance

Vol. 68 (May 7, 2003): Docket No. 03D-0112.  Draft Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols; Availability.  Pages  24486--24487 [FR Doc. 03-11214 ]  [ TXT ] [ PDF ] Comments August 5, 2003

The Draft Guidance

Vol. 68 (May 6, 2003): Docket No. 03D-0165.  Draft Guidance for Industry on the Current Good Manufacturing Practices for Medical Gases; Availability.  Pages  24005--24006 [FR Doc. 03-11073]  [ TXT ] [ PDF ] Comments September 4, 2003

The Draft Guidance pdf version
The Draft Guidance Word version

April

Vol. 68 (April 21, 2003): Docket No. 03D-0120.  Medical Devices: Draft Guidance for Industry and FDA Reviewers; Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns; Availability.  Pages  19549--19550 [FR Doc. 03-09661]  [ TXT ] [ PDF ] Comments July 21, 2003

The Draft Guidance

Vol. 68 (April 15, 2003): Docket No. 01D-0368.  Draft Guidance for Industry on Submitting Marketing Applications According to the ICH/CTD Format; General Considerations; Availability; Reopening of Comment Period.  Page  18248 [FR Doc. 03-09224]  [ TXT ] [ PDF ] Comments June 16, 2003

The Draft Guidance

Vol. 68 (April 4, 2003): Docket No. 03N-0094.  Annual Guidance Agenda.  Pages  16523--16541 [FR Doc. 03-08262]  [ TXT ] [ PDF ] Comments April 4, 2004

Vol. 68 (April 3, 2003): Docket No. 99D-1738.  Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability.  Pages  16292--16293 [FR Doc. 03-08010]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments July 2, 2003

The Draft Guidance

Vol. 68 (April 2, 2003): Docket No. 03D-0111.  Draft Guidance for Federal Agencies and State and Local Governments; Potassium Iodide Shelf Life Extension; Availability.  Pages  16063--16064 [FR Doc. 03-07817]  [ TXT ] [ PDF ] Comments June 2, 2003

The Draft Guidance (Word)
The Draft Guidance (PDF)

Vol. 68 (April 1, 2003): Docket No. 03N-0014, OC 200322.  Draft Guidance on Human Subject Protection; HHS Request for Comments.  Page  15731 [FR Doc. 03-7957]  [ TXT ] [ PDF ] Comments May 30, 2003

March

Vol. 68 (March 31, 2003): Docket No. 02N-0475.  Financial relationships and interests in research involving human subjects; protection guidance. NOTES: (1) Guidance document is included in the FR notice, and (2) Although displaying on an FDA web site and carrying an FDA Docket Number, this is a publication of the DEPARTMENT OF HEALTH AND HUMAN SERVICES.  Pages  15456--15460 [FR Doc. 03-07691 ]  [ TXT ] [ PDF ] Comments May 30, 2003

Vol. 68 (March 21, 2003): Docket No. 03D-0092.  Food and Cosmetic Security Guidances.  Pages  13932--13933 [FR Doc. 03-6843]  [ TXT ] [ PDF ] Comments May 20, 2003

The Draft Guidance -Foods-Retail
The Draft Guidance -Cosmetics

Vol. 68 (March 12, 2003): Docket No. 03D-0044.  Medical Devices: Draft Guidance for Industry and FDA Reviewers; Statistical Guidance on Reporting Results From Studies Evaluating Diagnostic Tests; Availability.  Pages  11871--11872 [FR Doc. 03-05792]  [ TXT ] [ PDF ] Comments June 10, 2003

The Draft Guidance

February

Vol. 68 (February 25, 2003): Docket No. 03D-0060.  Draft Guidance for Industry on Part 11, Electronic Records, Electronic Signatures--Scope and Application; Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide.  Pages  8775--8776 [FR Doc. 03-4312 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due April 28, 2003

The Draft Guidance (Word)
The Draft Guidance (PDF)

Vol. 68 (February 25, 2003): Docket No. 03D-0061.  Draft Guidance for Industry on Comparability Protocols--Chemistry, Manufacturing, and Controls Information; Availability.  Pages  8772--8773 [FR Doc. 03-4311]  [ TXT ] [ PDF ] Comments by June 25, 2003

The Draft Guidance (Word)
The Draft Guidance (PDF)

Vol. 68 (February 19, 2003): Docket No. 03D-0025.  Medical Devices: Draft Guidance for Industry and FDA; The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Availability.  Pages  8030-8031 [FR Doc. 03-3874]  [ TXT ] [ PDF ] Comments due May 20, 2003

The Draft Guidance

Vol. 68 (February 4, 2003): Docket No. 00D-1540.  Withdrawal of Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records.  Page  5645 [FR Doc. 03-02602]  [ TXT ] [ PDF ] Effective February 4, 2003

Vol. 68 (February 3, 2003): Docket No. 03D-0001.  Draft Guidance for Industry on Nonclinical Safety Evaluation of Pediatric Drug Products; Availability.  Pages  5301--5302 [FR Doc. 03-02376 ]  [ TXT ] [ PDF ] Comments May 5, 2003

The Draft Guidance (PDF)
The Draft Guidance (Word)

Vol. 68 (February 3, 2003): Docket No. 98D-0834.  Draft Guidance for Industry on Labeling for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Prescribing Information for Health Care Providers and Patient Labeling; Availability.  Pages  5300--5301 [FR Doc. 03-02377]  [ TXT ] [ PDF ] Comments April 4, 2003

The Draft Guidance (PDF)
The Draft Guidance (Word)

January

Vol. 68 (January 31, 2003): Docket No. 03D-0007.  Draft Guidance for Industry on Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommendations for Clinical Evaluation; Availability.  Pages  5025--5026 [FR Doc. 03-02213]  [ TXT ] [ PDF ] Comments April 1, 2003

The Draft Guidance

Vol. 68 (January 30, 2003): Docket No. 02D-0018.  Draft Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products; Availability,.  Pages  4788-4789 [FR Doc. 03-02162]  [ TXT ] [ PDF ] Comments March 31, 2003

The Draft Guidance

Vol. 68 (January 28, 2003): Docket No. 02D-0526.  Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information; Availability.  Pages  4219-4220 [FR Doc. 03-1919]  [ TXT ] [ PDF ] Comments by June 27, 2003

The Draft Guidance

Vol. 68 (January 27, 2003): Docket No. 02D-0525.  Medical Devices; Chemical Indicators Premarket Notification [510(k)] Submissions; Draft Guidance Industry and FDA; Availability.  Pages  3887--3888 [FR Doc. 03-1684]  [ TXT ] [ PDF ] Comments April 28, 2003

The Draft Guidance

Vol. 68 (January 16, 2003): Docket No. 02D-0492.  Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trails for Therapeutics in Adult Healthy Volunteers; Availability.  Pages  2340--2341 [FR Doc. 03-00906]  [ TXT ] [ PDF ] Comments March 17, 2003

The Draft Guidance pdf version
The Draft Guidance word version

Vol. 68 (January 9, 2003): Docket No. 02D-0509.  International Conference on Harmonisation; Draft Guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; Correction.  Page  1188 [FR Doc. 03-00360]  [ TXT ] [ PDF ]